Dasatinib Accord

Medicinal product

(Invented) name

Dasatinib Accord

Active substance (s)

Dazatinibas

Strength

70 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01EA02, dasatinib

Marketing authorisation holder

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2022-03-24

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	1 vnt.
Dazatinibas	70 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
108340	94444	1094444	lizdinė plokštelė	N56		Receptinis	EU/1/21/1540/009	Netiekiama	-	-	No	-	-
108341	94445	1094445	lizdinė plokštelė	N60		Receptinis	EU/1/21/1540/010	Netiekiama	-	-	No	-	-
108342	94446	1094446	dalomoji lizdinė plokštelė	N56×1		Receptinis	EU/1/21/1540/011	Netiekiama	-	-	No	-	-
108343	94447	1094447	dalomoji lizdinė plokštelė	N60×1		Receptinis	EU/1/21/1540/012	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-03-25	Išregistruotas
2022-03-24	Registruotas